ES2989678T3 - Respuesta dependiente del genotipo y de la dosis a un ASBTI en pacientes con deficiencia en la bomba de exportación de sales biliares - Google Patents

Respuesta dependiente del genotipo y de la dosis a un ASBTI en pacientes con deficiencia en la bomba de exportación de sales biliares Download PDF

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Publication number
ES2989678T3
ES2989678T3 ES20755296T ES20755296T ES2989678T3 ES 2989678 T3 ES2989678 T3 ES 2989678T3 ES 20755296 T ES20755296 T ES 20755296T ES 20755296 T ES20755296 T ES 20755296T ES 2989678 T3 ES2989678 T3 ES 2989678T3
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Prior art keywords
asbti
day
weeks
bile
administration
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ES20755296T
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English (en)
Spanish (es)
Inventor
Thomas Jaecklin
Alejandro Dorenbaum
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Mirum Pharmaceuticals Inc
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Mirum Pharmaceuticals Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4995—Pyrazines or piperazines forming part of bridged ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05—Dipeptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/08—Hepato-biliairy disorders other than hepatitis
    • G01N2800/085—Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Analytical Chemistry (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Pathology (AREA)
  • Plant Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ES20755296T 2019-02-12 2020-02-12 Respuesta dependiente del genotipo y de la dosis a un ASBTI en pacientes con deficiencia en la bomba de exportación de sales biliares Active ES2989678T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962804523P 2019-02-12 2019-02-12
US201962863904P 2019-06-20 2019-06-20
US201962908431P 2019-09-30 2019-09-30
US201962932015P 2019-11-07 2019-11-07
PCT/US2020/017951 WO2020167964A1 (fr) 2019-02-12 2020-02-12 Réponse dépendant du génotype et de la dose à un asbti chez des patients ayant une déficience de pompe d'exportation de sel biliaire

Publications (1)

Publication Number Publication Date
ES2989678T3 true ES2989678T3 (es) 2024-11-27

Family

ID=72044264

Family Applications (2)

Application Number Title Priority Date Filing Date
ES20755296T Active ES2989678T3 (es) 2019-02-12 2020-02-12 Respuesta dependiente del genotipo y de la dosis a un ASBTI en pacientes con deficiencia en la bomba de exportación de sales biliares
ES20756251T Active ES2982943T3 (es) 2019-02-12 2020-02-12 Métodos para aumentar el crecimiento en sujetos pediátricos con hepatopatía colestásica

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES20756251T Active ES2982943T3 (es) 2019-02-12 2020-02-12 Métodos para aumentar el crecimiento en sujetos pediátricos con hepatopatía colestásica

Country Status (17)

Country Link
US (11) US20220152022A1 (fr)
EP (7) EP4424363B1 (fr)
JP (6) JP2022520121A (fr)
KR (3) KR20210137466A (fr)
CN (4) CN114072152A (fr)
AU (4) AU2020221834B2 (fr)
BR (3) BR112021015799A2 (fr)
CA (3) CA3129826A1 (fr)
DK (1) DK3923943T3 (fr)
ES (2) ES2989678T3 (fr)
FI (1) FI3923943T3 (fr)
HR (3) HRP20260737T1 (fr)
IL (3) IL285495A (fr)
MX (4) MX2021009623A (fr)
PL (2) PL3923943T3 (fr)
PT (1) PT3923943T (fr)
WO (3) WO2020167964A1 (fr)

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SG11202108566VA (en) 2019-02-06 2021-09-29 Albireo Ab Benzothiadiazepine compounds and their use as bile acid modulators
CN113453753B (zh) 2019-02-06 2024-07-23 阿尔比里奥公司 苯并硫氮杂环庚三烯化合物及其用作胆汁酸调节剂的用途
EP4424363B1 (fr) * 2019-02-12 2026-04-29 Mirum Pharmaceuticals, Inc. Procédés pour augmenter la croissance chez des sujets pédiatriques présentant une maladie hépatique cholestatique
CN114786772B (zh) 2019-12-04 2024-04-09 阿尔比里奥公司 苯并硫杂(二)氮杂环庚三烯化合物及其作为胆汁酸调节剂的用途
CA3158195A1 (fr) 2019-12-04 2021-06-10 Per-Goran Gillberg Composes de benzothia(di)azepine et leur utilisation en tant que modulateurs de l'acide biliaire
JP7665621B2 (ja) 2019-12-04 2025-04-21 アルビレオ・アクチボラグ ベンゾチアゼピン化合物及び胆汁酸モジュレータとしてのそれらの使用
ES3002777T3 (en) 2020-08-03 2025-03-07 Albireo Ab Benzothia(di)azepine compounds and their use as bile acid modulators
CN116710100A (zh) * 2020-11-12 2023-09-05 阿尔比里奥公司 用于治疗进行性家族性肝内胆汁淤积(pfic)的奥德昔巴特
AU2021379076A1 (en) 2020-11-12 2023-06-08 Albireo Ab Odevixibat for treating progressive familial intrahepatic cholestasis (pfic)
BR112023010799A2 (pt) 2020-12-04 2023-10-03 Albireo Ab Compostos de benzotia(di)azepina e seus usos como moduladores de ácidos biliares
CN117412955A (zh) 2021-06-03 2024-01-16 阿尔比里奥公司 苯并硫杂(二)氮杂环庚三烯化合物及其作为胆汁酸调节剂的用途
TW202333723A (zh) * 2021-10-26 2023-09-01 美商米魯姆製藥公司 頂端鈉依賴型膽酸轉運蛋白抑制劑(asbti)之給藥方法
TW202333722A (zh) * 2021-10-26 2023-09-01 美商米魯姆製藥公司 頂端鈉依賴型轉運蛋白抑制劑組合物
TW202333724A (zh) * 2021-11-05 2023-09-01 美商米魯姆製藥公司 以迴腸膽酸轉運蛋白(ibat)抑制劑治療以增加無事件存活期(efs)
CN119053330A (zh) * 2022-04-22 2024-11-29 阿尔比里奥公司 皮下给药asbt抑制剂
CN120091821A (zh) * 2022-10-23 2025-06-03 米鲁姆制药公司 治疗进行性家族性肝内胆汁淤积症的方法
AU2023374724A1 (en) 2022-11-03 2025-05-01 Albireo Ab Treating alagille syndrome (algs)
EP4629997A1 (fr) * 2022-12-09 2025-10-15 Albireo AB Inhibiteurs d'asbt dans le traitement de maladies rénales
US12296050B2 (en) * 2023-10-05 2025-05-13 Mirum Pharmaceuticals, Inc. Pharmaceutical compositions comprising maralixibat and uses thereof
CN122094694A (zh) 2023-11-03 2026-05-26 阿尔比里奥公司 使用奥维昔巴特治疗pfic2
WO2025235543A1 (fr) * 2024-05-07 2025-11-13 Mirum Pharmaceuticals, Inc. Méthodes de traitement du prurit cholestatique

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